MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. HUGO; MECHANICAL WALKER

Model Number 700-959E

Device Problem Unintended Movement (3026)

Patient Problems Abrasion (1689); Fall (1848); Unspecified Infection (1930)

Event Date 09/10/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare received notification of an incident involving a rollator that drive imports and distributes.The patient was attempting to rise out of the rollator when reportedly the unit rolled out under him causing him to fall to the ground.The patient was taken to emergency room where it was discovered that he suffered skin abrasions and infections on his right arm.Patient received the rollator fully assembled without instructions.Drive is in the process of obtaining the unit in question.

• Brand Name: HUGO
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town, zhongshan city, guangdong 51000 0; CH 510000
• MDR Report Key: 6956361
• MDR Text Key: 89564450
• Report Number: 2438477-2017-00079
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/17/2017,09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 700-959E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Distributor Facility Aware Date: 09/17/2017
• Event Location: Other
• Date Report to Manufacturer: 10/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 73